Schizophrenia patients have increased risk of cardiovascular disease (CVD) and mortality. Guidelines emphasise need for monitoring risk factors including ECG and blood pressure (BP). There is little naturalistic data on number and severity of categorical abnormalities detected.

A global health clinic was set up in 2004 to undertake systematic physical health monitoring in all schizophrenia outpatients within Larkfield CMHT. Patients received 2 hour assessments from trained nurses. BMI, laboratory (non-fasting) parameters, ECG and BP performed.

Since 2004 from 140 Schizophrenia outpatients 95 have been invited to attend screening of which 53 accepted (56%). An abnormal parameter was measured in 92% (n=49), 72% 2 abnormal findings (n=38) and 47% 3 or more. ECG abnormalities in 50% (n=26) of which 18 were significant findings (prior myocardial infarction and/or ischaemia, conduction blocks, right ventricular hypertrophy). Normal blood pressure using guidelines from British Hypertension Society (BHS) 2004 (<130/85) was determined in 36% (n=20), high-normal 11% (n=6) and varying grades of hypertension 53% (n=27). Grade 3 (severe) hypertension 8% (n=4). No patient had abnormal QTc >500 mscs. One male patient had QTc 458msecs.In 18 patients (34%) the ECG analysis was determined by the analyser to be difficult to analyse due to significant baseline patient movement.

Significant BP and ECG abnormalities are common and require evaluation for treatment. QTc abnormalities are detected significantly less often than other important abnormalities. Using the most conservative definition of hypertension 53% of this cohort would be defined as needing antihypertensive treatments and lifestyle interventions in 64%.

Increasing attention is paid to importance of hyperprolactinaemia. Sexual dysfunction and osteoporosis are reported in such patients. There is little naturalistic data showing prevalence and severity of hyperprolactinaemia in asymptomatic patients receiving antipsychotics.

All outpatients in a community mental health team in Halifax receiving antipsychotics with diagnosis of schizophrenia or bipolar disorder had prolactin measurements. Upper Limit of Normal (ULN) prolactin 500mIU/L (males) and 700mIU/L (females).

Prolactin levels were obtained in 226 patients providing 253 incident cases as antipsychotic changes were made over 36-month period.

Abnormal values were found in 49% females and 29% males - 39% of the cohort. Levels >1000 mIU/L were seen in 23% (females 36%, males 10%). From the 61/125 females with abnormal levels, 74% of these had levels >1000 mIU/L and 16/125 (13%) >2000 mIU/L. Only 13/128 males had levels >1000 mIU/L. Prevalence of hyperprolactinaemia in those on antipsychotic monotherapy: olanzapine 7%, typicals 33%, amisulpride 92%, Clozapine 4%, risperidone oral 83%, and risperidone consta 65%. In Risperidone Consta patients, 15/23 (65%) had hyperprolactinaemia including 100% of females (10/10). Most females on oral risperidone (12/13) also had hyperprolactinaemia and had values >1000 mIU/L in11/12.

Routine prolactin screening showed abnormal values in 39% and significantly abnormal levels (>1000 mIU/L) that could lead to drug/dosage alterations in 23%. Exceptionally high levels >2000 mIU/L were found in 7%. Females on oral and consta risperidone may be particularly at risk of the effects of hyperprolactinaemia.

Characterizing the profile of schizophrenic patients with high hospitalization rates seems relevant. The aim of this study is to describe characteristics of patients with schizophrenia hospitalized at Acute Care Units, and identify clinical profiles associated to relapse.

Observational retrospective study (case-control). Hospitalized patients diagnosed for schizophrenia or schizoaffective disorder for more than 2 years. Data related to the previous 3 years and current hospitalization were recorded: sociodemographics, diagnosis, CGI, reason for current/previous hospitalizations, life events, drug abuse, therapy prior and during hospitalization and compliance.

Preliminary results from 1607 patients are presented: cases are patients with no hospitalization (No-HOSP) in the previous 3 years (N=508); controls are those who had some hospitalization (HOSP) during that period (N=1099). HOSP patients were significantly younger than No-HOSP (p<0.0001). 41% of HOSP and 28.4% of No-HOSP patients showed No-Low family support (p<0.0001). 55.9% of HOSP and 50.2% of No-HOSP patients showed some drug abuse close to current hospitalization (p<0.05). The most frequent factor for current hospitalization was relapse due to non-compliance in both HOSP (66.2%) and No-HOSP (59.4%; p=0.0092). Through artificial intelligence methods, fourteen variables are identified as related to relapse (Number of previous antipsychotics, Time of evolution, CGI, Age, Gender, Educational Level, Family support, Compliance, Heroine, Cocaine or Cannabis abuse, Stressing events, Diagnosis, Number of previous hospitalizations), which have permitted to develop a predictive model for relapse (PRECOG Project).

The main factor for hospitalization was non-compliance. Age, family support, drug abuse seem to be also related to hospitalization.

Insight in schizophrenia shows critical implications for adherence. Non-adherence is particularly relevant in first-episode patients. Few studies have examined insight in early schizophrenia. The aim of this study is to examine relationship between insight, adherence and outcome in patients with early schizophrenia.

Observational study in patients diagnosed for schizophrenia, schizophreniform, or schizoaffective disorder for less than 5 years. Data are collected retrospectively from first psychotic episode to study start, and prospectively (1 year). Association of demographic data, clinical measures, remission, relapses, and adherence with level of insight (Scale to Assess Unawareness of Mental Disorder and G12 item of PANSS) was evaluated. Adherence was assessed interviewing patients and family. Remission was defined according to Remission in Schizophrenia Working Group criteria. Preliminary data are shown.

575 patients have been analyzed. Duration of illness was 3.9±1.6 years. According to G12 item of PANSS, almost 50% of patients had moderate to extreme impairment in baseline insight, while this percentage was 15.8% at 12 mo. (N=291). At baseline, 50% of patients showed good adherence to medication (>80%), and adherence rose to 78% at 12 mo. (N=291). Remission (severity criteria) significantly increased from baseline (23.9%, N=574) to 12 mo. (59.5%, N=291; p<0.0001). A significant relationship between insight and remission at baseline (p<0.001) was found. Among patients who reached 12 mo. visit (N=289), hospitalization was more frequent in those with poor baseline insight.

Lack of insight is common in early schizophrenia and may be a relevant predictor of poor outcome.

Non-compliance is very common among patients with mental disorders, especially in schizophrenia. Non-compliance increases risk of relapse, hospitalizations, and suicide attempts, which worsens outcome. The aim of this study is to evaluate adherence to a new-onset therapeutic strategy in patients with schizophrenia, and the methods used to evaluate it. Differences between schizophrenia and other mental disorders will be assessed.

Epidemiological study in outpatients diagnosed for schizophrenia, bipolar disorder, depression or personality disorder in which a new therapeutic approach was started (pharmacological or non pharmacological). Retrospective information from the previous three months (sociodemographic and clinical characteristics, treatments, adherence) and prospective data (adherence) for the three months after new therapy start were collected.

Preliminary results from 975 patients with schizophrenia are presented. In 83% of patients with schizophrenia, adherence to pharmacological treatment was assessed through questions to the patient or some relative (caregiver o no direct caregiver), while in 10.5%, 12.6%, 17.3% and 23.7% it was assessed through MARS and DAI scales, MEMS, tablets account, and injections delivery. When patient was asked about his compliance with pharmacological treatment, 48% stated optimal compliance (>80% of doses prescribed), while this percentage is reduced to 44%, 38.5% and 35% when more objective methods were used (tablets account, MARS scale or MEMS, respectively). Compliance rose to 80% in patients treated with long-acting injectable antipsychotics.

Less of 50% of patients with schizophrenia show optimal compliance to oral pharmacological treatment, while this rate is 80% among those treated with long-acting injectable antipsychotics.

Many outpatients with schizophrenia experience severe metabolic side effects such as metabolic syndrome that occurs frequently in the treatment with some atypical antipsychotics that especially with clozapine and olanzapine.

To determine whether antipsychotic-associated metabolic abnormalities identified through intensive monitoring can be changed by switching from olanzapine medication to ziprasidone in patients with schizophrenia.

Stable outpatients with metabolic side effects on olanzapine (n=20) therapy were switched to a flexible-dose trial of ziprasidone (40-160 mg/day) in this 13-week naturalistic study. All patients underwent an extensive metabolic evaluation at baseline, at 6 weeks, and at 13 weeks post switch. Metabolic abnormalities included the following medical complications: new onset diabetes impaired fasting glucose, impaired glucose tolerance, metabolic syndrome according to various definitions, and dyslipidemia. After 13 weeks of treatment with ziprasidone (mean daily dose 136.4 mg), there was a significant decrease in body weight, body mass index, and waist circumference. There was a significant reduction in fasting glucose, fasting insulin, and serum lipids levels (cholesterol, triglycerides, low-density lipoprotein (LDL), LDL/HDL, Chol/HDL, and non-HDL cholesterol). The metabolic syndrome was reversed in 70% of patients at 3 months.

Switching stable outpatients with schizophrenia from olanzapine to ziprasidone was generally well tolerated and was associated with improvements at 13 weeks. Results support the reversibility of olanzapine-induced metabolic abnormalities when detected early and followed by a switch to ziprasidone.

Schizophrenia requires new antipsychotic that can relieve suffering and improve the prognosis of schizophrenic patients.

To study efficacy and safety of Ariprazole in patients with acute schizophrenia.

We studied 16 patients with acute episode of schizophrenia, 6 were first episodes and 10 acute reactivations. We used ARIPRAZOLE for 6 months to evaluate its effectiveness and tolerance. All patients were hospitalised and received Ariprazole in progressively larger doses, beginning with 10 mg/day and increasing to 30 mg at 10 days. Evaluation measures were PANSS, initial and 6 months, and CGI, initial (severity) and 6 months (evolution-improvement). Side effects were evaluated.

Mean PANSS in first episodes: 85 at onset and 36 at 6 months; in reactivations: 75 at onset and 32 at 6 months. ICG showed a mean severity of 4.6 in the first episodes and 4.2 in reactivations; at 6 months the mean improvement was 2.3 in the first episodes and 2.3 in reactivations. The transitory side effects were found, which did not require discontinuation of the drug: insomnia in 15% of first episodes and in 22% of reactivations; nausea in 16% vs. 22%; a certain disinhibition (not manic) in 83% of first episodes and in 77% of reactivations.

ARIPRAZOLE is an effective antipsychotic in the first and successive episodes of schizophrenia. It improved insight and the subjective feeling of well-being and made the psychotic condition easier to bear. This definitely made it a drug of first choice for acute or reactivated schizophrenia.

We present the results of one year follow up with 76 schizophrenic patients treated with long-acting risperidone (medium-high dose 50-75mg/biweekly).The efficacy and safety of this new risperidone formulation was the focus of our study.

We studied during a year follow up, 76 patients diagnosed of schizophrenia (DSM-IV criteria). Long-acting Risperidone was started (day 0) if uncompliance, or relapse with previous treatments in a regimen dose of 50mg. biweekly. Evaluations were performed at day 0, and at 6, 9, and 12 months of follow up. We used as parameters of efficacy: the PANSS, and the CGI.

65 (85%) kept the initial dose of 50mg biweekly, while 7 patients needed 75mg biweekly at the sixth month, and two patients required suplementary oral dose of 4-6mg of Risperidone. Total mean PANSS at first evaluation was 56 and decreased to a mean of 38 in the group treated with 50mg, 37 points those treated with 75mg. at the end of one year. The CGI changed from an initial 2.8 mean punctuation at baseline to a mean of 1.9 points in the group treated with 50mg, decreased to a mean of 2 points in the group treated with 75mg.

15% of the whole sample relapsed during the follow up of one year and 11 (14.7%) required hospitalisation

Secondary effects when present, were rated as mild.

We hardly believe that long-acting Risperidone at 50-75mg (medium-high doses) is an efficacy and well tolerated treatment, for schizophrenia.

Depot Clinic is a relevant tool in the management of chronic psychotic patients in the ambulatory setting, since it allows monitoring attendance to consultation, compliance, and facilitates patient's follow-up.

The aim of this study is to improve knowledge about the Depot Clinic at our Center, checking adherence and retention rates to the treatments.

Retrospective review of medical records of all patients that have attended our Center to receive long-acting medication in the last 36 months. Sociodemographic, clinical and treatment data were recorded, as well as information about hospitalizations, compliance with visits, need of additional medication (oral antipsychotics or corrective medication), etc.

Ninety-six patients were included in the analysis. Mean age was 44.8 y and mean time since diagnosis was 17.34 y. Sixty-seven of them were diagnosed with schizophrenia. 55% of patients received risperidone (RLAI), 27% fluphenazine decanoate and 17.7% zuclopentixol. Patients receiving RLAI had been under that treatment for 2.6 y.,; those with zuclopentixol and fluhenazine treatments had been receiving them for 6.81 and 11.54 y., respectively. Half of patients treated with RLAI and two thirds of those receiving fluphenazine had oral antipsychotics prescribed as well. Corrective treatment was used in 24%, 64% and 80% of patients receiving RLAI, zuclopentixol and fluphenazine, respectively. Among those patients treated with RLAI, retention rate was 66%, while 9% of patients decided to withdraw the treatment themselves.

RLAI is the most frequently used antipsychotic in our Depot Clinic. This drug has a retention rate over 60% after a 3-year follow-up.

Two-years naturalistic study investigating adherence to therapy, tolerability, functionality and quality of life (QoL) of 400 patients with early schizophrenia under treatment with the only available atypical depot (CONSTA) and other oral atypicals (OATYP).

Planned interim-analysis comprised 179 patients (ITT population; baseline to endpoint). Thereof, 89 patients started treatment with CONSTA, 90 patients with one of six OATYP (11 Olanzapin, 16 Quetiapine, 11 Amisulpride, 16 Ziprasidone, 18 Aripiprazole, 18 Risperidone). Mean age was 32.7 for CONSTA and 34.6 years for OATYP cohort. Mean duration of schizophrenia (82%: F20.0) was 2.7 years (SD 1.6) for both groups.

There were baseline differences between CONSTA and OATYP cohort with regard to reasons for starting treatment (non-compliance 56% vs 18%; lack of tolerability 22% vs 31%, respectively) and severity of illness (PANSS total 94 vs 87). With regard to change of therapy, there was a tendency towards higher retention rates and mean study duration in the CONSTA cohort (56% vs 47%, p=0.23; 395 vs 342 days). PANSS scores improved significantly for both cohorts (CONSTA -17.2 vs OATYP -16.3). EPS score improved with no significant differences between cohorts. Overall, reported AEs related to schizophrenia (psychosis 14%; agitation 9.5%) were most common, followed by weight gain (9.5%) and fatigue (9%).

In this prospective, non-randomized study, interim-analysis from 45% of 400 planned patients with initial CONSTA or OATYP treatment shows comparable improvement of psychopathology and EPS and a tendency towards higher treatment adherence with CONSTA, considering initially more non-compliant patients in this group.

Early-onset psychosis (EOP) are a heterogeneous group, with high diagnostic stability for schizophrenia and bipolar disorder, in contrast to the lack of diagnostic stability of other EOP.

We recruited 24 adolescents consecutively admitted, who presented a first psychotic episode, in the adolescent psychiatric unit of the Gregorio Marañón General Hospital in Madrid, between May 2002 and May 2003, for a two year follow-up. Only one was lost at the two-year assessment.

Diagnosis of the psychotic disorders was assessed using the Kiddie-Sads-Present and Lifetime Version (K-SADS-PL).

The agreement between the baseline and the one-year follow-up diagnoses was 54.2%. Positive Predictive Value (PPV) was 100% for schizophrenia and depression with psychotic features, and 71.4% for bipolar disorder, while only 50.0% for schizo-affective disorder and 16.7% for psychosis NOS. From the one-year to the two-year follow-up, only one patient changed the diagnosis, so the agreement was 95.7%.

Eight patients were diagnosed with schizophrenia at the follow-up, but only four of them had received this diagnosis at the baseline assessment. The diagnosis of bipolar disorder was given at the follow-up to eight patients, from whom only four subjects received this diagnosis at baseline.

The results of the our longitudinal study on diagnostic stability support the Kraepelinean distinction between dementia praecox and manic-depressive psychosis.

Reports about the course of pregnancy in women treated with atypical antipsychotics are rare.

Case report of a woman who presented an overdose with olanzapine during pregnancy. Results : Ms. A. was a 21-year-old Caucasian woman with a 3-years history of schizophrenia according to the DSM-IV criteria. She was successfully treated with olanzapine during 2 years before the onset of pregnancy. While Ms. A was stabilized with olanzapine treatment, she became pregnant. Olanzapine treatment was switched to haloperidol 10mg/day at week 2 of gestation. However, she stopped haloperidol after 15 days. While she stopped antipsychotic treatment, her symptoms increased, particularly irritability, anxiety, attentional disorders and dizorganized behaviors. At week 16 of gestation, feeling psychological distress, she took 112.5 mg of olanzapine of her own. Olanzapine was started again after giving her informed consent. She showed significant symptomatic improvement and received olanzapine 7.5mg/day from week 16 of gestation until delivery. She had no side effects from olanzapine treatment, in particular blood sugar levels were normal, from 4.6 to 5.4 mmol/l. Her weight was 60 kg (BMI=20) before the onset of pregnancy, 72 kg at the delivery. At week 37, a healthy baby girl was delivered. The baby weighed 3.415 kg. Her height was 52 cm. Her Apgar scores were 7 at 1 minute and 7 at 5 minutes. Ms. A did well and was discharged 12 days after delivery to improve her psychosocial education. However, more studies are needed to ascertain the safety of olanzapine during pregnancy.

To compare 12 month outcomes in schizophrenia patients enrolled in e-STAR in Spain who received RLAI or oral antipsychotics.

e-STAR is a secure, web-based, international, long-term observational study of schizophrenia patients who commence a new antipsychotic drug. PS was applied to adjust for baseline differences in patients who received RLAI or oral (atypical or conventional) antipsychotics to compare all-cause discontinuation rates, hospitalisation parameters, and Global Assessment of Functioning (GAF).

Data from 1,332 (83%) patients who initiated RLAI and 268 (17%) who initiated a new oral antipsychotic are available. Significant raw baseline differences existed for hospitalisation parameters, unemployment and time since diagnosis, each being more prevalent in the RLAI group. Nevertheless, a significantly greater proportion of patients remained on RLAI at 12 months (84%) than on oral antipsychotics (60.4%) (p<0.0001); this benefit persisted after application of PS. The mean number of days hospitalised at 12 months was 14.3 days lower in the RLAI group (12.9 days, n=433) than in the oral antipsychotic group (27.2 days, n=62) increasing to 19.1 days, significantly in favour of RLAI, when PS was applied (p<0.01 vs oral). The probability of being in hospital was lower in RLAI patients (OR 0.69) and decreased further after PS (OR 0.57)(p=0.075). GAF scores improved more in the RLAI group than the oral group at 12 months, with and without PS, but not significantly.

Although patients initiating RLAI were more severely ill, they had fewer hospitalisations and were less likely than oral antipsychotic patients to discontinue treatment.